Arvinas

Director, Clinical Operations

Arvinas

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Oversee strategy and implementation of all sponsored clinical trials within Arvinas’ development pipeline.
  • Drive a pre-clinical study into Phase I and through clinical development.
  • Ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards.
  • Ensure that appropriate company infrastructure and quality systems are in place to support all clinical trials.
  • Lead execution of clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Arvinas SOPs.
  • The Director will report to the Executive Director, Clinical Operations and can work from a remote location within the US.
  • Build department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
  • Ensure external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
  • Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
  • Builds collaborative relationships with key stakeholders including Medical, Regulatory Affairs, CMC/Supply Chain, IT, Legal, Finance departments, and project teams as needed to support clinical programs.
  • Collaborate with KOLs for feedback on study protocols and development plans.
  • Implement and lead a Clinical Development Team
  • Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
  • Review and Clean Global Clinical Study data.
  • Prepare IB and DSUR Documentation.
  • Prepare Clinical Documentation.
  • Develop protocol paradigm to anticipate protocol execution and preparation of investigators.

Requirements

  • 12+ years of strong hands-on experience leading clinical trials execution.
  • Minimum 5 years in supervisory role managing clinical operations staff.
  • Ability to take a leadership role, motivate staff, and drive high quality execution.
  • Oncology therapeutic area experience required or multi-therapeutic clinical operations experience.
  • Experience managing a study from pre-clinical to clinical phase.
  • Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Effective communication and interpersonal skills; effective interaction with senior management
  • Flexibility to travel as required.
  • Preferred experience with Investigational New Drug applications (INDs).
  • Preferred medical writing experience.
  • Clinical pharmacology study experience is desirable
  • Arvinas will not be providing VISA sponsorship for this position now or in the future. You must have the ability to work without a need for a current or future VISA sponsorship
  • The duties of this role are generally conducted in a home office environment. Employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.